New draft regulations announced by Israel's Ministry of Health called "Pharmacists' Regulations (Cosmetics), 5783-2022"

News Date
January 24, 2023

Israel has informed the WTO about new proposed rules titled "Pharmacists' Regulations" that have been made public by the Israel Ministry of Health in order to safeguard the public's health. Israel's Ministry of Health has proposed new laws governing the manufacture, distribution, and import of cosmetics. The proposed regulations cover safety evaluations, raw material use, and directions for testing scents.

The regulations propose various instructions and requirements for perfume producers, importers, and marketers, including the definition of terms like "batch" and "serious side effect," the details and paperwork needed to register with the registry of perfumers, and the specifications for production, storage, and distribution processes.

A professional safety assessment must be performed by a person who holds a licence to practise medicine, a licence as a pharmacist, or a degree in chemistry, toxicology, or the life sciences, according to the proposed regulation, which also establishes additional requirements for the appointment of a responsible representative.

Additionally, the proposed regulations suggest creating a presumption of normality for the findings of tests on microbial load, yeasts and moulds, and the absence of pathogenic bacteria in perfumery. They also propose adding more information to the notices on the marketing of medications with nano components.

There are numerous annexes that control the use of particular components, such as those that are prohibited, restricted, or permitted in cosmetics.

If a company wants to lawfully manufacture, import, and promote cosmetics in Israel, it must make sure that it complies with these rules.

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